Associate Director, Risk Based Quality Management Lead

Overview of Role:

The Associate Director, Risk-Based Quality Management (RBQM Lead) is accountable for the operational execution of RBQM activities across assigned clinical studies. Serving as the primary RBQM subject matter expert within study teams, this role implements and maintains study-level risk management, centralized monitoring, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), targeted monitoring strategies, and risk review processes.

Working closely with Clinical Operations, Clinical Science, Data Management, Biostatistics, Medical Monitoring, and CRO partners, the RBQM Lead proactively identifies, evaluates, escalates, and mitigates risks throughout the clinical trial lifecycle to support participant safety, data reliability, and regulatory compliance.

Role and Responsibilities:

Study-Level RBQM Execution

• Serve as the RBQM Lead and core study team member from protocol development through study closeout

• Lead RBQM planning, execution, and ongoing risk oversight throughout study conduct.

• Develop and maintain study-specific RBQM Plans and Critical-to-Quality (CtQ) factors, ensuring alignment with protocol objectives and identified study risks.

Risk Assessment & Risk Management

• Facilitate cross-functional risk identification and assessment workshops and lead creation and maintenance of study Risk Assessment and Categorization Tools (RACTs).

• Document, score, track, and periodically reassess risks, identifying new or emerging risks from study performance data and operational signals.

• Collaborate with study teams to implement risk mitigation strategies and actions, monitor their effectiveness, and recommend additional interventions when needed.
  

Key Risk Indicator (KRI) Management

• Develop and maintain study-specific KRIs linked to identified risks and CtQ factors, including thresholds, triggers, and escalation pathways.

• Review and interpret KRI outputs and investigate threshold breaches and root causes.

• Facilitate study-team RBQM reviews and track KRI trends, actions, and mitigation outcomes.

Quality Tolerance Limit (QTL) Oversight

• Collaborate with study teams to establish protocol-specific QTLs

• Monitor QTL performance throughout study conduct.

• Investigate QTL excursions and assess potential impact on participant safety and data integrity.

• Coordinate documentation of investigations, assessments, and corrective actions.

• Present QTL findings during study governance reviews.

Central Monitoring:

• Lead the implementation of centralized monitoring strategies across multiple clinical trials

• Monitor and review clinical trial data across sites to ensure accuracy, completeness, and

consistency with study protocols.

• Conduct routine centralized monitoring reviews, through performing real-time data surveillance to identify outliers, trends, and potential issues that could impact data integrity.

• Analyze data visualizations, listings, dashboards, and statistical outputs.

• Identify unusual data patterns, quality concerns, and site-specific risks.

• Evaluate trends across subjects, sites, countries, and regions.

• Assess effectiveness of ongoing monitoring activities.

• Generate risk summaries and recommendations for study teams.

• Escalate significant findings requiring additional oversight.

• Conduct risk-based monitoring activities, such as assessing site performance, patient safety

data, and identifying sites at risk of data discrepancies or protocol violations.

• Utilize central monitoring tools and platforms (e.g., RBQM, EDC, CTMS) to track study progress and ensure data consistency.

• Support data query resolution by coordinating with site and CRO teams and ensuring timely

data corrections.

Study Risk Review Meetings

• Lead recurring study risk review meetings to update the RACT and risk registers and facilitate cross-functional risk-management decisions.

• Prepare dashboards and study risk summaries and present significant risk signals, KRI trends, QTL status, and mitigation activities.

• Track decisions and action items and ensure timely follow-up.
  

Site Risk Surveillance

• Review site-level risk profiles and identify high-risk sites requiring additional oversight.

• Partner with Clinical Operations, CRO teams, CRAs, Data Management, Medical Monitoring, and other stakeholders to develop and implement site-specific action plans.

• Monitor the effectiveness of interventions at high-risk sites and escalate persistent quality concerns.
  

Issue Management & CAPA Support

• Support investigations of significant quality events and compliance issues, including root cause analyses.

• Contribute to the definition of corrective and preventive actions (CAPAs) and quality improvement plans and monitor the effectiveness of proposed actions throughout the conduct of the study.

Inspection Readiness

• Maintain inspection-ready documentation of risk assessments, KRI and QTL reviews, centralized monitoring activities, findings, corrective actions, and recommendations.

• Support sponsor audits, regulatory inspections, and quality-control checks, including preparation of RBQM-related responses and data-review reports.

• Prepare monitoring reports summarizing findings, trends, and recommendations for improvements to the study team in support of the preparation for internal and regulatory audits

• Ensure RBQM activities comply with GCP, ICH guidelines, FDA regulations, and other applicable regulatory requirements.

• Participate in internal quality assurance activities and continuous improvement initiatives.

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas preferred.

• 10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations.

• 7+ years of direct RBQM, centralized monitoring, risk-based monitoring, clinical quality, or study management experience.

• Experience supporting global Phase II and/or Phase III clinical trials.

• Experience conducting risk assessments; developing and managing KRIs and QTLs; and facilitating risk review meetings.

• Demonstrated ability to interpret complex scientific, clinical, and operational data to identify quality and compliance risks and support centralized trial monitoring.

• Experience working with CROs, RBQM technology and clinical analytics platforms.

• Proven ability to oversee large, complex studies managed in-house and through CRO partners.

• Demonstrated sound judgment and problem-solving ability related to regulatory requirements, external partners, timelines, and complex clinical programs.

• Excellent planning, communication, negotiation, and organizational skills.

• Strong knowledge of the drug development process, ICH guidelines, and GCP, with a deep understanding of clinical trial execution and the ability to apply this knowledge to complex global studies.